Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
2 linked reportsMalfunction 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2020-03 | 0 | 1 |
| 2020-06 | 0 | 1 |
| 2020-07 | 0 | 1 |
| 2021-03 | 0 | 2 |
| 2021-10 | 0 | 2 |
| 2021-12 | 0 | 2 |
| 2022-01 | 0 | 2 |
| 2022-05 | 0 | 1 |
| 2022-09 | 0 | 1 |
| 2023-01 | 0 | 1 |
| 2023-02 | 0 | 1 |
| 2023-07 | 0 | 2 |
| 2023-08 | 0 | 1 |
| 2023-12 | 0 | 1 |
| 2024-01 | 0 | 4 |
| 2024-03 | 0 | 2 |
| 2024-08 | 0 | 9 |
| 2025-01 | 0 | 2 |
| 2025-02 | 0 | 2 |
| 2025-03 | 0 | 2 |
| 2025-05 | 0 | 2 |
| 2025-07 | 0 | 6 |
| 2025-10 | 0 | 2 |
| 2025-11 | 0 | 6 |
| 2025-12 | 2 | 2 |
| 2026-01 | 0 | 6 |
Failure-mode summaryAI-generated
2 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-12-08 | 3004964738-2025-00001 | Malfunction | Available | exact di |
Showing the most recent 1 of 2 linked reports.
Regulatory clearances
Predicate lineage
Cited as predicate by: K180608
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2013-07-24 | VAI | Voluntary action indicated | Advanced Brain Monitoring Inc | 3 |
| 2013-07-24 | VAI | Voluntary action indicated | Advanced Brain Monitoring Inc | 3 |
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